Recovery After Stress Toolkit (RESET) Study

University of Utah93 enrolled

Overview

This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.

As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Post-Traumatic Stress Disorder in Children Post-Traumatic Stress Disorder in Adolescence

Interventions

RESETBEHAVIORAL

Therapy

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 8 years to 17 years at enrollment * Treated for an injury in the ED or hospitalized * Abbreviated Injury Scale (AIS) score 2 or greater * Parent and child English speaking * Broad band internet availability at home * Residing with parent or legal guardian Exclusion Criteria: * Moderate or severe traumatic brain injury (GCS less than 13) * Diagnosed with moderate or severe intellectual disability * Pre-existing psychiatric disorder that required hospitalization * Abuse or interpersonal injury as mechanism of injury * Currently receiving psychotherapy * Hospitalized for injury over 30 ays * Death of a family member or friend at time of injury

Locations (3)

Cincinnati CHildren's Hospital

Cincinnati, Ohio, United States

University of Texas Health Sciences Center

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Child PTSD Symptom Scale (CPSS)

17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. We used the combined child report and parent report. The highest item score from either parent or child was summed.

Time frame: 10 weeks post-randomization

Secondary Outcomes

Screen for Anxiety Related Emotional Disorders (SCARED)

41-item survey with three point Likert scale responses (not sure, somewhat true, very true) that asks about common difficulties for children with anxiety. Higher scores indicate worse outcomes. Range 0-82

Time frame: 10 weeks post-randomization

Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms

PROMIS pediatric item bank : 8 questions with a 5-point Likert response from Never to Almost Always. Higher scores means more depressive symptoms. T-score with mean = 50; Standard Deviation (SD)=10.

Time frame: 10-weeks post-randomization

Pediatric Quality of Life Inventory (PedsQL)

15 question scale based on physical, emotional, social and school functioning answered on a 5-point Likert scale (never to almost always). Score is 0 - 100 with higher scores indicating better HRQoL. Parent proxy scale.

Time frame: 10-weeks

Data from ClinicalTrials.gov

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